Tiziana Life Sciences plc ("Tiziana" or the "Company") Tiziana Announces Initiation of Phase 1 Clinical Trial with Nasal Administration of Foralumab, a Fully Human Anti-Cluster Definition 3 Monoclonal Antibody (anti-CD3

("Tiziana" or the "Company")

Announces Initiation of Phase 1 Clinical Trial with Nasal Administration of Foralumab, a Fully Human Anti-Cluster Definition 3

Monoclonal Antibody (anti-CD3 mAb), in Healthy Volunteers

breakthrough approach for treatment of neurodegenerative diseases such as progressive multiple sclerosis

28 November 2018 - Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS), a UK biotechnology company that focuses on

the discovery and development of novel molecules to treat human disease in oncology and immunology, previously announced that

it had submitted an Investigational New Drug (IND) application on 1 June 2018 to the U.S. Food and Drug Administration (FDA).

Following approval of the IND application by the FDA, the Company announces that a first-in-human Phase 1 clinical trial in healthy

volunteers has been initiated at the Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

in a stable formulation will be nasally administered by a dose-escalating regimen starting at 10, 50 and 250 g/day, using

a nasal spray device. This Phase 1 clinical trial in healthy volunteers will evaluate safety and tolerability of Foralumab. The

clinical protocol also includes evaluation of unique biomarkers of immunomodulation, induction of T regulatory cells (Tregs) and

anti-inflammation to assess therapeutic potential of the treatment.

administration with anti-CD3 mAbs induces Tregs in the cervical lymph node that then cross the blood brain barrier and provide

an interleukin-10 dependent anti-inflammatory signal to downregulate the activated glial cells in brain and return them to their

normal homeostatic state. Thus, this is an exciting, innovative and physiological approach to stimulate the mucosal immune system

to induce disease modifying Tregs", commented Dr. Howard Weiner, a member of scientific advisory board of Tiziana.

delivery of therapeutic anti-CD3 mAb is a game changer that employs immune mechanisms overcoming the obstacle of the blood brain

barrier and it has the potential as entirely new class of therapies for treatment of a wide range of human diseases",

said Gabriele Cerrone, Chairman and founder of Tiziana.

this IND for nasal administration of Foralumab is a first and major milestone towards the Company's objective to develop

innovative therapies with alternative routes of administration whilst maximizing efficacy.

also plan to submit a similar IND for a Phase 1b clinical trial with encapsulated and enteric-coated formulation of Foralumab

in healthy volunteers to evaluate safety and tolerability in the first quarter of 2019. A well-established panel of blood biomarkers

will be examined to assess potential of orally administered Foralumab for treatment of autoimmune and inflammatory diseases such

as non-alcoholic fatty liver disease (NASH) and Crohn's disease", commented Kunwar Shailubhai, CEO and CSO of

Howard L. Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners

Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham & Women's

Hospital in Boston. He has pioneered immunotherapy in MS and has investigated immune mechanisms in nervous system diseases including

MS, Alzheimer's disease, amyotrophic lateral sclerosis, stroke and brain tumors. He has also pioneered the investigation

of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce Tregs for the

treatment of these diseases.

Harvard Medical Centre

and Women's Hospital (BWH) is located adjacent to Harvard Medical School, of which it is the second largest teaching affiliate.

It is the largest hospital of the Longwood Medical and Academic Area in Boston, Massachusetts, USA. With Massachusetts General

Hospital, it is one of the two founding members of Partners HealthCare, the largest healthcare provider in Massachusetts. BWH

conducts the second largest hospital-based research program in the world, with an annual research budget of more than $630 million.

Pioneering milestones include the world's first successful heart valve operation and the world's first solid

Autoimmune Diseases and Foralumab

diseases constitute a major medical problem and include diseases such as multiple sclerosis, type 1 diabetes, rheumatoid arthritis

and inflammatory bowel disease. Other diseases that have inflammatory components include diseases such as NASH, atherosclerosis

and stroke. The induction of regulatory cells at mucosal surfaces by the oral or nasal administration of antigens has been shown

to treat a large variety of autoimmune and inflammatory diseases in animal models with minimal toxicity. Foralumab was developed

by Novimmune and was acquired by Tiziana. Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release

of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine

release syndrome (CRS) and improves the overall safety profile of Foralumab.

a humanized mouse model (NOD/SCID IL2 c-/-) developed in Dr. Kevan Herold's laboratory, it was shown that while targeting

the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances Tregs and thus provides

therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually

associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of

Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction

Tiziana Life Sciences

is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease

in oncology and immunology. In addition to milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is

the only fully human anti-CD3 mAbs in clinical development in the world. This compound has potential application in a wide range

of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative

colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where

modulation of a T-cell response is desirable.

more information go to http://www.tizianalifesciences.com